Quality Assurance Manager
2 weeks ago
Argon Medical Devices Inc is seeking a Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement quality strategies to support customer needs and business objectives
- Provide solutions to difficult problems relating to quality aspects of design, validation, and manufacture of medical devices
- Manage supplier quality, customer feedback, process control, internal audits, change management, and design control
- Serve as management representative for regulatory inspections and responsible engineering manager
- Implement systems for product quality standards and procedures, including in-coming material quality, in-process product quality, and out-going product quality plans
- Perform Adverse Event Evaluation and manage QA staff to ensure compliance with all Argon and government regulatory/statutory requirements
Requirements:
- Bachelor's degree in science, math, or engineering discipline
- CQA or CBA or RABSQA, CQE certifications required; CQMgr/OE, Lean, CSSGB/CSSBB certifications preferred
- Minimum years of work experience in regulated healthcare environment
- Experience in transfer of design to manufacturing, including coordination with sister companies
- Strong validation/verification skills for equipment and processes
- Experience with PFMEA/FMEA and ISO 14971 Risk Management
- Measurement Systems Analysis, Gage R&R, and development of inspection test methods
- Previous success leading and mentoring a team in a collaborative environment
- Strong analytical and problem-solving skills
- Ability to prioritize for maximum results (multi-task management)
- Function successfully in a high-paced results-oriented team environment
- Self-motivated, quick learner, productive team member
- Excellent communication skills (verbal and written)
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